Thank you for joining us at the 2016 CDISC Europe Interchange. Presentation slides from the conference are available below. We look forward to seeing you again at future CDISC events!
Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.
Session 1 - Opening Plenary:
Opening Keynote Address - Why do clinical research during an epidemic?
Dr. Amanda Rojek, University of Oxford
Dr. Nicole Harmon, CDISC
Barrie Nelson, CDISC
Session 2 - Second Plenary:
Dr. Fergus Sweeney and Enrica Alteri, EMA
Our Way to CDISC Submissions – Where We Are Now
Dr. Yuki Ando, PMDA
Dr. Eileen Navarro, Dr. Lilliam Rosario and Dr. Steve Wilson, FDA
Session 3 - Therapeutic Area Standards and Implementations:
Challenges in Adapting the Diabetes Therapeutic Area User Guide
Anja Lundgreen and Mikkel Traun, Novo Nordisk
Data Standards Development for Vaccines Reactogenicity
Anne-Sophie Bekx, Business and Decision
Adapting the CDISC Data Models to Support Regulatory Submissions for Modified Risk Tobacco Products
Sarah Merlet, Philip Morris International
Thoughts on How to Integrate Therapeutic Area User Guide SDTM Implementation into the Overall SDTM Model
Johannes Ulander and Niels Both, S-cubed
Therapeutic Area User Guide – Follow-Up
Diane Wold, CDISC
Session 4 - SHARE:
Update on CDISC SHARE
Lauren Becnel, CDISC
The SHARE API Pilot Project: An Overview and Update
Sam Hume, CDISC
Understanding the Potential of SHARE: A Visual Business and Technical Use Case
Peter Van Reusel, Chairman of CDISC E3C
Session 5 - CFAST:
CFAST Program Status and Project Pipeline - Fellows
Rhonda Facile, CDISC
JCFAST Update
Dr. Mayumi Shikano, Japan PMDA
FDA Specification Project
Diane Wold, CDISC
Current Thinking on TAUGs and Their Contents
Diane Wold and Rhonda Facile, CDISC
Oncology Projects and SHARE
John Owen and Rhonda Facile, CDISC
Solving SDTM Modeling Challenges for Several Infectious Diseases Collectively
Bess LeRoy and John Neville, C-Path
Session 6 - Governance:
How Internal Standards Governance Teams Enable the Adoption of External CFAST Standards into the Company Global Data Standards
Jenny Griffiths, F.Hoffmann-La Roche
Version Management: Bringing Order and Assessing the Impact of Change
Dave Iberson-Hurst, Assero Ltd.
Managing Data Standards Libraries Compliance
Deborah Paletta, Business & Decision
Governance: A Foundational Framework for Data Standards Implementation from TransCelerate
Sofie Inari Castella, Novo Nordisk
Submission Experiences: Ensuring Compliance
Sara Pauwels, Johnson & Johnson
Session 7 - Semantics, MDR and Automation:
Using OWL to Classify Adverse Events in an SDTM/ADaM Workflow
William Stevens, Nuffield Department of Population Health, Oxford University
Study Builder: Using CDISC Standards and Semantic Technology to Drive the Automation of Study Database Build
Chris Price, F. Hoffman-La Roche AG
A Practical Implementation of Integrated Medical Standards at Bayer and Lessons Learned
Susanne Pangritz, Bayer Healthcare and Djenan Ganic, Intilaris LifeSciences
Implementation and Management of Studies’ Metadata
Jean Miguet, Danone
Session 8 - SEND:
Issues Seen with SEND Submissions and Their Impact on Data Reviewability
Gitte Frausing, Data Standards Decisions Aps
Preclinical Studies – Not Just Clinical Studies with Animals Or Why Preclinical Has it Easier than Clinical
Mike Harwood, Instem
Session 9 - Foundational Standards:
CDISC Implementation on Hemophilia Trial Data
Malathi Hari, Larix A/S
Associated Persons – Digging Deeper: A Case Study
Yaroslav Sud, Chiltern
Lost in Traceability, from SDTM to ADaM ... Finally Analysis Results Metadata
Angelo Tinazzi, Cytel
Session 10 - Broaden CDISC and Connect to the World:
The Standard Integrative Frameworks for Therapeutic Clinical Data in Translational Research
Paul Houston and Dorina Bratfalean, CDISC
An Approach to Combining Disparate Clinical Study Data Across Multiple Sponsor’s Studies Participating in Project Data Sphere®
Gene Lightfoot, SAS
Clinical Trial Register – Version 2
Paul Houston, CDISC
Session 11 - CDISC Success and Vision:
PhUSE CSS Feedback Session
Stephen Bamford, PhUSE
Organizational Implementation of CDISC Standards and Impact on Metrics: A Case Study
Anne Bush, Chiltern
Less is More – A Visionary View on the Future of CDISC Standards
Jozef Aerts, University of Applied Sciences FH Joanneum
Digitalization in Life Sciences - Data is the New Pill - Standardization is Core
Anders Helmø Larsen, SAS
Session 12 - Closing Plenary:
Closing Keynote Address: Meaningful Involvement of Patients in Life Science Multi-Stakeholder Initiatives
Dr. Scott Wagers, IMI